DIAMONDTEMP Adverse Events: FDA MAUDE Data
EPIX THERAPEUTICS · Cardiac Ablation Catheter for Atrial Fibrillation
Total Reports
110
Reports (30d)
0
Active Signals
0
Open Recalls
6
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Catheter Vacuum Leak During Cryoablation
umbilical, cryoablation, completed cryo, balloon catheter, result event
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Feb 22, 2021 · Open, Classified
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
Feb 22, 2021 · Open, Classified
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
Feb 22, 2021 · Open, Classified
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
Feb 22, 2021 · Open, Classified
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
Feb 22, 2021 · Open, Classified
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
Feb 22, 2021 · Open, Classified
It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
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